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Spots Global Cancer Trial Database for Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

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Trial Identification

Brief Title: Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

Official Title: A Phase 1 Study of Selinexor (KPT-330), A Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Study ID: NCT02323880

Study Description

Brief Summary: This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) or the maximum tolerated dose (MTD) of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. II. To describe the toxicities of selinexor in children with recurrent/refractory solid and CNS tumors. III. To characterize the pharmacokinetics of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. SECONDARY OBJECTIVES: I. To determine the antitumor effect of selinexor in a preliminary manner in children with recurrent/refractory solid and CNS tumors. II. To determine the pharmacodynamic properties of selinexor in children and adolescents with refractory solid tumors in plasma proteins and whole blood ribonucleic acid (RNA). III. To explore the penetration, pharmacodynamic effects, and biologic effects of selinexor in tumor tissue of patients with recurrent/refractory high-grade gliomas (HGG) requiring resection. IV. To further assess the toxicity and antitumor effects of selinexor in children with recurrent/refractory HGG in expanded cohorts following dose-escalation by measuring rate of objective radiographic response (medical patients) and rate of progression-free survival (PFS) six months from the start of treatment (surgical patients). OUTLINE: This is a dose escalation study. Patients receive selinexor PO on either a twice weekly (days 1, 3, 8, 10, 15, 17) or once weekly (days 1, 8, 15, and 22) schedule. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Keywords

Eligibility

Minimum Age: 12 Months

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Children's National Medical Center, Washington, District of Columbia, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Oregon Health and Science University, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

Seattle Children's Hospital, Seattle, Washington, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Contact Details

Name: Julia Glade-Bender

Affiliation: COG Phase I Consortium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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